Clinical Trial Details

Trial ID: L0216
Source ID: NCT04767529
Associated Drug: Efruxifermin
Title: A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Acronym: Harmony
Status: Active, not recruiting
Study Results: No Results Available
Results: --
Conditions: NASH - Nonalcoholic Steatohepatitis
Interventions: Drug: EFX|Drug: Placebo
Outcome Measures: Change from baseline in liver fibrosis with no worsening steatohepatitis assessed by NASH CRN system|Resolution of steatohepatitis with no worsening of fibrosis assessed by the NASH CRN system|Change from baseline in liver fibrosis with no worsening of steatohepatitis assessed by the NASH CRN system|Responder based on NASH CRN: patients who had a decrease of ??? one point in fibrosis score|Change from baseline in hepatic fat fraction|Change from baseline of lipoproteins - Non-HDL-C, HDL-C, and LDL-C|Change from baseline of markers of glycemic control - HbA1c|Change from baseline of markers of glycemic control - C-Peptide|Change from baseline of markers of glycemic control - Adiponectin|Change from baseline of markers of glycemic control - HOMA-IR|Change from baseline of non-invasive fibrosis biomarkers - ELF|Change from baseline of non-invasive fibrosis biomarkers - Pro-C3|Change from baseline of non-invasive fibrosis biomarkers - NIS-4|Change from baseline of non-invasive fibrosis biomarkers - liver stiffness assessed by transient elastography (FibroScan??)|Change from baseline of body weight
Sponsor/Collaborators: Akero Therapeutics, Inc
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 128
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: February 16, 2021
Completion Date: May 2024
Results First Posted: --
Last Update Posted: February 14, 2022
Locations: Akero Clinical Study Site, Chandler, Arizona, United States|Akero Clinical Study Site, Glendale, Arizona, United States|Akero Clinical Study Site, Tucson, Arizona, United States|Akero Clinical Study Site, North Little Rock, Arkansas, United States|Akero Clinical Study Site, Chula Vista, California, United States|Akero Clinical Study Site, Fresno, California, United States|Akero Clinical Study Site, La Jolla, California, United States|Akero Clinical Study Site, Los Angeles, California, United States|Akero Clinical Study Site, Los Angeles, California, United States|Akero Clinical Study Site, Los Angeles, California, United States|Akero Clinical Study Site, Orange, California, United States|Akero Clinical Study Site, Rialto, California, United States|Akero Clinical Study Site, Santa Ana, California, United States|Akero Clinical Study Site, Fort Myers, Florida, United States|Akero Clinical Study Site, Inverness, Florida, United States|Akero Clinical Study Site, Lakewood Ranch, Florida, United States|Akero Clinical Study Site, Miami Lakes, Florida, United States|Akero Clinical Study Site, Miami, Florida, United States|Akero Clinical Study Site, Miami, Florida, United States|Akero Clinical Study Site, Ocala, Florida, United States|Akero Clinical Study Site, Sarasota, Florida, United States|Akero Clinical Study Site, Marietta, Georgia, United States|Akero Clinical Study Site, Topeka, Kansas, United States|Akero Clinical Study Site, Baton Rouge, Louisiana, United States|Akero Clinical Study Site, Marrero, Louisiana, United States|Akero Clinical Study Site, Ypsilanti, Michigan, United States|Akero Clinical Study Site, Flowood, Mississippi, United States|Akero Clinical Study Site, Jackson, Mississippi, United States|Akero Clinical Study Site, Las Vegas, Nevada, United States|Akero Clinical Study Site, Charlotte, North Carolina, United States|Akero Clinical Study Site, Durham, North Carolina, United States|Akero Clinical Study Site, Morehead City, North Carolina, United States|Akero Clinical Study Site, Cincinnati, Ohio, United States|Akero Clinical Study Site, Greenville, South Carolina, United States|Akero Clinical Study Site, Hermitage, Tennessee, United States|Akero Clinical Study Site, Nashville, Tennessee, United States|Akero Clinical Study Site, Arlington, Texas, United States|Akero Clinical Study Site, Austin, Texas, United States|Akero Clinical Study Site, Cedar Park, Texas, United States|Akero Clinical Study Site, Dallas, Texas, United States|Akero Clinical Study Site, Dallas, Texas, United States|Akero Clinical Study Site, Edinburg, Texas, United States|Akero Clinical Study Site, Fort Worth, Texas, United States|Akero Clinical Study Site, Garland, Texas, United States|Akero Clinical Study Site, Houston, Texas, United States|Akero Clinical Study Site, San Antonio, Texas, United States|Akero Clinical Study Site, San Antonio, Texas, United States|Akero Clinical Study Site, San Antonio, Texas, United States|Akero Clinical Study Site, San Marcos, Texas, United States|Akero Clinical Study Site, Webster, Texas, United States|Akero Clinical Study Site, Charlottesville, Virginia, United States|Akero Clinical Study Site, Richmond, Virginia, United States|Akero Clinical Study Site, Richmond, Virginia, United States|Akero Clinical Study Site, San Juan, Puerto Rico
URL: https://ClinicalTrials.gov/show/NCT04767529

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D414 Efruxifermin Biological drug -- Fibroblast growth factor receptor agonist anti-fibrotic, improves metabolic status Under clinical trials Details